Unable to Generate PMDA E2B when Study J License field is blank
(Doc ID 2237219.1)
Last updated on FEBRUARY 01, 2021
Applies to:Oracle Argus Safety Japan Cloud Service - Version 8.0 and later
Information in this document applies to any platform.
E2B report for PMDA agency is unable to be generated on a study case when Argus Console >> Business Configuration >> Studies >> J Data Entry >> Products block >> License field is missing/blank.
(When LM_STUDY_PRODUCTS.PRIMARY_PMDA_PRODUCT_LIC_ID is NULL.)
PMDA ICSR Validation Report message:
J.12.i.1 MHLWINDICATIONFORSTUDY Target Disease
J.12.i.2 MHLWPHASEOFSTUDIES Study Development Phase
J.12.i.3 MHLWNUMBOFPTUNDERTREATMENT Are any subjects given this investigational drug?
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